Leukemia Clinical Trial
Official title:
The Metabolic Syndrome in Pediatric Acute Lymphoblastic Leukemia (ALL).
RATIONALE: Gathering information about metabolic syndrome from young patients with acute
lymphoblastic leukemia may help doctors learn more about the disease.
PURPOSE: This phase I trial is studying the metabolic syndrome in young patients with acute
lymphoblastic leukemia in remission.
OBJECTIVES:
Primary
- To determine the incidence and prevalence of the components of metabolic syndrome
(e.g., obesity, hypertension, dyslipidemia, and insulin resistance) in pediatric
patients with acute lymphoblastic leukemia in remission.
- To determine the trajectory of the onset of these components over a 1-year period in
patients undergoing maintenance therapy.
Secondary
- To identify potential associations between components of metabolic syndrome and
fatigue, health-related quality of life, family history, nutrition, and physical
activity.
- To identify potential biomarkers that are associated with clinical features of
metabolic syndrome.
- To evaluate whether patients will show a decrease in IGF-1 levels.
OUTLINE: This is a two-part study. Patients are enrolled in either part 1 or part 2.
- Part 1: Patients undergo physical exam measurements (e.g., body mass index, waist
circumference, and blood pressure) at baseline (during maintenance course 1) and at 12
months (during maintenance course 5). Patients also undergo blood sample collection at
baseline and at 12 months to measure laboratory markers (e.g., fasting lipid profile,
fasting insulin and glucose, IGF-1, leptin, and adiponectin levels). Patients or their
parents complete a family history questionnaire at baseline and questionnaires to
assess physical activity, quality of life, nutritional intake, and fatigue at baseline
and at 6 and 12 months.
- Part 2: Patients or their parents complete a family history questionnaire at baseline.
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